FDA Device Recalls

Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Class IIOngoing

Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Allura Xper FD20/15; System Code: 722058;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Allura Xper FD20/20; System Code: 722038;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Allura Xper FD10C; System Code: 722001;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

Class IOngoing

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

Class IOngoing

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159

Civco Medical Instruments Co. Inc.